Trial Outcomes & Findings for Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty. (NCT NCT02127281)

NCT ID: NCT02127281

Last Updated: 2018-09-19

Results Overview

Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: Within 90 days after surgery
• Results posted on: 2018-09-19

Participant Flow

Participant milestones

Measure	Prevena Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control A standard of care sterile wound dressing will be placed.
Overall Study STARTED	80	80
Overall Study COMPLETED	79	80
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Prevena Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control A standard of care sterile wound dressing will be placed.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.

Baseline characteristics by cohort

Measure	Prevena n=80 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 Participants A standard of care sterile wound dressing will be placed.	Total n=160 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	45 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized White	65 Participants n=5 Participants	66 Participants n=7 Participants	131 Participants n=5 Participants
Race/Ethnicity, Customized Non-white	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Body mass index	31.9 kg/m^2 n=5 Participants	33.4 kg/m^2 n=7 Participants	32.7 kg/m^2 n=5 Participants
Charlson comorbidity index 0	32 Participants n=5 Participants	24 Participants n=7 Participants	56 Participants n=5 Participants
Charlson comorbidity index 1	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Charlson comorbidity index >=2	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants
American Society of Anesthesiologists score =<2	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
American Society of Anesthesiologists score >=3	66 Participants n=5 Participants	70 Participants n=7 Participants	136 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 90 days after surgery

Population: 80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat. 80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat

Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.

Outcome measures

Measure	Prevena n=79 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 Participants A standard of care sterile wound dressing will be placed.
Number of Patients With Wound Complications	9 participants	22 participants

PRIMARY outcome

Timeframe: Within 90 days after surgery

Population: 80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat. 80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat

Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision

Outcome measures

Measure	Prevena n=79 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 Participants A standard of care sterile wound dressing will be placed.
Re-operation Rates	5 Participants	11 Participants

PRIMARY outcome

Timeframe: Within 90 days after surgery

Population: 80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat. 80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat

Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision

Outcome measures

Measure	Prevena n=79 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 Participants A standard of care sterile wound dressing will be placed.
Readmission Rates	16 Participants	16 Participants

SECONDARY outcome

Timeframe: 4 weeks postoperative

Mean knee flexion (degrees) at 4 weeks postoperatively

Outcome measures

Measure	Prevena n=27 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=31 Participants A standard of care sterile wound dressing will be placed.
Knee Flexion	89.7 degrees Standard Deviation 21.6	88.9 degrees Standard Deviation 23.3

SECONDARY outcome

Timeframe: 90 days postoperative

Population: The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups

Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.

Outcome measures

Measure	Prevena n=79 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 Participants A standard of care sterile wound dressing will be placed.
HOOS and KOOS Scores at 90 Days Postoperatively HOOS ADL	64.1 units on a scale Standard Deviation 23.9	66.4 units on a scale Standard Deviation 25.3
HOOS and KOOS Scores at 90 Days Postoperatively HOOS Pain	72.4 units on a scale Standard Deviation 23.7	70.3 units on a scale Standard Deviation 26.5
HOOS and KOOS Scores at 90 Days Postoperatively HOOS QOL	42.7 units on a scale Standard Deviation 21.3	37.9 units on a scale Standard Deviation 26.6
HOOS and KOOS Scores at 90 Days Postoperatively HOOS Symptoms	71.3 units on a scale Standard Deviation 17.4	70.2 units on a scale Standard Deviation 23.5
HOOS and KOOS Scores at 90 Days Postoperatively KOOS ADL	60.5 units on a scale Standard Deviation 24.7	54.3 units on a scale Standard Deviation 22.9
HOOS and KOOS Scores at 90 Days Postoperatively KOOS pain	57.1 units on a scale Standard Deviation 24.9	55.8 units on a scale Standard Deviation 25.5
HOOS and KOOS Scores at 90 Days Postoperatively KOOS symptoms	58.9 units on a scale Standard Deviation 18.1	55.9 units on a scale Standard Deviation 20.2

SECONDARY outcome

Timeframe: 90 days postoperative

Population: The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups

Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.

Outcome measures

Measure	Prevena n=79 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 Participants A standard of care sterile wound dressing will be placed.
HOOS and KOOS Scores at 90 Days Postoperatively HOOS sports/rec	18.8 units on a scale Interval 6.3 to 34.4	21.9 units on a scale Interval 6.3 to 48.4
HOOS and KOOS Scores at 90 Days Postoperatively KOOS QOL	43.8 units on a scale Interval 25.0 to 62.5	34.4 units on a scale Interval 14.1 to 43.8
HOOS and KOOS Scores at 90 Days Postoperatively KOOS sports/rec	0 units on a scale Interval 0.0 to 25.0	10 units on a scale Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: 4 weeks postoperatively

Median Timed-up-and-go test (seconds)

Outcome measures

Measure	Prevena n=53 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=39 Participants A standard of care sterile wound dressing will be placed.
Timed-up-and-go Test	25 seconds Interval 14.3 to 37.0	24.2 seconds Interval 15.0 to 39.1

SECONDARY outcome

Timeframe: 4 weeks postoperative

Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively

Outcome measures

Measure	Prevena n=25 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=23 Participants A standard of care sterile wound dressing will be placed.
Hip Range of Motion (Flexion)	73.6 degrees Standard Deviation 22.9	75.3 degrees Standard Deviation 25

SECONDARY outcome

Timeframe: 90 days postoperatively

Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively.

Outcome measures

Measure	Prevena n=68 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=60 Participants A standard of care sterile wound dressing will be placed.
VR-12 Questionnaire PCS	33.3 z-score Standard Deviation 9.6	31.5 z-score Standard Deviation 10.3
VR-12 Questionnaire MCS	50.2 z-score Standard Deviation 12.3	46.6 z-score Standard Deviation 14.1

SECONDARY outcome

Timeframe: 4 weeks postoperative

Median hip range of motion (extension, in degrees) at 4 weeks postoperatively

Outcome measures

Measure	Prevena n=24 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=22 Participants A standard of care sterile wound dressing will be placed.
Hip Range of Motion	5 degrees Interval 0.0 to 10.0	0 degrees Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 4 weeks postoperative

Median knee extension (degrees) at 4 weeks postoperatively

Outcome measures

Measure	Prevena n=32 Participants Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=31 Participants A standard of care sterile wound dressing will be placed.
Knee Extension	5 degrees Interval 0.0 to 10.0	5 degrees Interval 0.0 to 10.0

Adverse Events

Prevena

Serious events: 26 serious events

Other events: 9 other events

Deaths: 0 deaths

Control

Serious events: 31 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prevena n=80 participants at risk Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 participants at risk A standard of care sterile wound dressing will be placed.
Infections and infestations Prosthetic Joint Infection	1.2% 1/80 • Number of events 1 • 90 days	2.5% 2/80 • Number of events 2 • 90 days
Musculoskeletal and connective tissue disorders Dislocation	2.5% 2/80 • Number of events 2 • 90 days	0.00% 0/80 • 90 days
Blood and lymphatic system disorders Venous Thrombosis	2.5% 2/80 • Number of events 2 • 90 days	2.5% 2/80 • Number of events 2 • 90 days
Investigations Readmission	20.0% 16/80 • Number of events 16 • 90 days	20.0% 16/80 • Number of events 16 • 90 days
Investigations Reoperation	6.2% 5/80 • Number of events 5 • 90 days	13.8% 11/80 • Number of events 11 • 90 days

Other adverse events

Measure	Prevena n=80 participants at risk Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days). Prevena: Device will be applied at end of procedure over closed incision.	Control n=80 participants at risk A standard of care sterile wound dressing will be placed.
Skin and subcutaneous tissue disorders Wound drainage	11.2% 9/80 • Number of events 9 • 90 days	27.5% 22/80 • Number of events 22 • 90 days
Respiratory, thoracic and mediastinal disorders mild edema (lung)	0.00% 0/80 • 90 days	2.5% 2/80 • Number of events 2 • 90 days

Additional Information

Alison K. Klika, MS, Research Manager, Department of Orthopaedic Surgery

Cleveland Clinic

Phone: (216) 444-4954

Email: klikaa@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place